Breast Cancer SurvivorsNCT02753985
Adherence to Aromatase Inhibitors: The Role of Partners
An observational study of Breast Cancer Survivors, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
This is a qualitative study which explores the role that partners play in breast cancer survivors adherence to aromatase inhibitors and management of their side effects. Both patients and their partners will be interviewed (separately) in order to capture multiple perspectives. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Survivors
- What is being tested?
- Survey
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 22 Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women and partners of women with stage I-III breast cancer
Who may be able to join
- Women and partners of women with stage I-III breast cancer who
- have completed primary cancer treatments (surgery, chemotherapy, radiotherapy)
- have experienced AI side effects
- live with a romantic partner.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This is a qualitative study which explores the role that partners play in breast cancer survivors adherence to aromatase inhibitors and management of their side effects. Both patients and their partners will be interviewed (separately) in order to capture multiple perspectives. The target number of subjects is 64 (32 patients and 32 partners). The primary method of data collection will be face-to-face semi-structured interviews. These interviews will be audio-recorded.
- Conditions
- Breast Cancer Survivors
- Being tested
- Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Surveys Completed
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startJul 2014
- Primary completion22 Apr 2016
- Study completion22 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Mao, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753985
- Sponsor's protocol ID
- UPCC 15114
- Status last verified
- Jul 2019
- First submitted
- 26 Apr 2016
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Aromatase Inhibitors: The Role of Partners
- ClinicalTrials.gov ID
- NCT02753985
- Acronym / sponsor ID
- UPCC 15114
- Conditions
- Breast Cancer Survivors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 22 Apr 2016 (actual)
- Study completion
- 22 Apr 2016 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a qualitative study which explores the role that partners play in breast cancer survivors adherence to aromatase inhibitors and management of their side effects. Both patients and their partners will be interviewed (separately) in order to capture multiple perspectives. The target number of subjects is 64 (32 patients and 32 partners). The primary method of data collection will be face-to-face semi-structured interviews. These interviews will be audio-recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women and partners of women with stage I-III breast cancer
Key inclusion criteria (4 listed)
- Women and partners of women with stage I-III breast cancer who
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey | Other | – |
Primary outcome
Number of Surveys Completed
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Mao, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Survivors, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Surveys Completed (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.